When Is An Investigator Brochure Not Required
What is when is an investigator brochure not required?
A when an investigator brochure is not required when there is already an existing comprehensive report or document that contains all the necessary information about the investigational product. This report or document should cover aspects such as the pharmacokinetics, pharmacodynamics, and toxicology of the product.
What are the types of when is an investigator brochure not required?
There are two types of situations when an investigator brochure is not required. The first type is when the investigational product is already approved for another indication, and the second type is when the investigational product is a new formulation of an already approved product.
How to complete when is an investigator brochure not required
To complete when an investigator brochure is not required, you need to ensure that all the necessary information about the investigational product is already available in the existing comprehensive report or document. Additionally, you should clearly state the type of situation that exempts the need for an investigator brochure.
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